FDA 510(k) Applications for Medical Device Product Code "OLW"
(Index-Generating Electroencephalograph Software)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K003038 | AGILENT TECHNOLOGIES DEUTSCHLAND GMBH | AGILENT COMPONENT MONITORING SYSTEM, AGILENT V24/26, AGILENT BIS MODULE, MODEL M1175A/76A/77A,REV.L,M1205A,REV.L,M1034A | 12/15/2000 |
| K010965 | ALARIS MEDICAL SYSTEMS, INC. | A-LINE AEP MONITOR | 06/27/2001 |
| K963644 | ASPECT MEDICAL SYSTEMS, INC. | A-1000 EEG MONITOR AND A-1050 EEG MONITOR | 10/08/1996 |
| K974496 | ASPECT MEDICAL SYSTEMS, INC. | A-2000 EEG MONITOR WITH BIS | 02/06/1998 |
| K062613 | ASPECT MEDICAL SYSTEMS, INC. | BIS EEG MONITOR VIEW | 06/18/2007 |
| K052362 | ASPECT MEDICAL SYSTEMS, INC. | BIS EEG MONITOR, MODEL A-3000 | 09/09/2005 |
| K052981 | ASPECT MEDICAL SYSTEMS, INC. | BIS EEG MONITOR, MODEL BISX4 | 11/01/2005 |
| K072286 | ASPECT MEDICAL SYSTEMS, INC. | BIS EEG VISTA MONITOR SYSTEM AND BISX | 11/20/2007 |
| K002837 | ASPECT MEDICAL SYSTEMS, INC. | BIS ENGINE | 09/19/2000 |
| K011834 | ASPECT MEDICAL SYSTEMS, INC. | BIS ENGINE | 07/10/2001 |
| K040183 | ASPECT MEDICAL SYSTEMS, INC. | BISX | 02/25/2004 |
| K011534 | ASPECT MEDICAL SYSTEMS, INC. | EEG MIS MONITOR MODEL # A-2000; BIS ENGINE | 06/15/2001 |
| K030267 | ASPECT MEDICAL SYSTEMS, INC. | EEG MONITOR WITH BIS, MODEL A-2000 | 01/15/2004 |
| K031694 | ASPECT MEDICAL SYSTEMS, INC. | MODIFICATION TO EEG MONITOR WITH BIS, MODEL A-2000 | 08/29/2003 |
| K213273 | Cortical Dynamics Ltd | Brain Anesthesia Response Monitor (Bar Monitor) | 09/01/2023 |
| K042315 | DANMETER A/S | CEREBRAL STATE MONITOR - CSM | 01/21/2005 |
| K013389 | DATEX-OHMEDA | DATEX-OHMEDA S/5 BIS MODULE, M-BIS AND ACCESSORIES | 01/10/2002 |
| K023459 | DATEX-OHMEDA | DATEX-OHMEDA S/5 ENTROPY MODULE, M-ENTROPY AND ACCESSORIES | 01/13/2003 |
| K060997 | EVEREST BIOMEDICAL INSTRUMENTS CO. | SNAP II EEG MONITOR | 06/15/2006 |
| K052145 | GE HEALTHCARE | DATEX-OHMEDA S/5 BIS MODULE, E-BIS AND ACCESSORIES | 08/23/2005 |
| K050835 | GE HEALTHCARE | DATEX-OHMEDA S/5TM ENTROPY MODULE, E-ENTROPY AND ACCESSORIES | 05/06/2005 |
| K061907 | GE HEALTHCARE | MODIFICATION TO: DATEX-OHMEDA S/5 ENTROPY MODULE, E-ENTROPY AND ACCESSORIES | 03/27/2008 |
| K150298 | GE HEALTHCARE FILAND OY | Entropy Module, E-ENTROPY-01 | 11/12/2015 |
| K012466 | GENERAL ELECTRIC MEDICAL SYSTEMS INFORMATION TECHN | BIS/EEG MODULE | 10/01/2001 |
| K203113 | Masimo Corporation | Masimo SedLine Sedation Monitor and Accessories | 02/25/2022 |
| K172890 | Masimo Corporation | SedLine Sedation Monitor | 01/26/2018 |
| K083063 | MENNEN MEDICAL LTD. | BIS INTERFACE FOR VITALOGIK PATIENT MONITORS | 12/16/2008 |
| K071899 | MENNEN MEDICAL LTD. | BIS MODULE FOR ENVOY PATIENT MONITOR | 10/22/2007 |
| K033543 | MT MONITORTECHNIK GMBH & CO. KG | NARCOTREND, MODEL COMPACT 4.0 | 09/17/2004 |
| K202621 | NeuroWave Systems Inc. | NeuroSENSE Monitoring System, Model NS-901 | 08/05/2021 |
| K020218 | NICOLET BIOMEDICAL, INC. | SNAP EEG MONITOR | 04/22/2002 |
| K001069 | PHYSIOMETRIX, INC. | MODEL 4000 EEG MONITOR WITH PSI (PSA4000) | 06/30/2000 |
| K020671 | PHYSIOMETRIX, INC. | PSA4000 EEG MONITOR WITH FRONTAL PSI | 10/04/2002 |
| K051874 | PHYSIOMETRIX, INC. | SEDLINE SEDATION MONITOR WITH FRONTAL PSI AND SEDTRACE EEG ELECTROSE SET | 09/02/2005 |
| K033999 | PHYSIOMETRIX, INC. | SEDLINE WITH FRONTAL PSI | 02/06/2004 |
| K060900 | SPACELABS MEDICAL INC. | SPACELABS MEDICAL BISPECTRAL INDEX (BISX) ANALYSIS MODULE 91482 AND ACCESSORIES MODEL-91842 | 06/23/2006 |
| K973596 | SPACELABS MEDICAL, INC. | SPACELABS MEDICAL 90482 BISPECTRAL INDEX ANALYSIS (BIS) MODULE | 02/03/1998 |
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